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Cra Ii / Sr Cra (Delhi, Mumbai, Ahmd, Bangalore, Hyderabad)

4+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Both the CRA II and Sr CRA positions at Syneos Health share several commonalities and overlapping responsibilities, yet differ slightly in their qualifications and expectations due to the seniority of the roles. Here's a summary to distinguish the two:

Common Responsibilities

  • Monitoring & Compliance: Conducting site qualification, initiation, interim monitoring, and close-out visits while ensuring adherence to ICH-GCP, regulatory requirements, and protocols.
  • Informed Consent Verification: Reviewing and verifying processes related to subject/patient consent and data confidentiality.
  • Data Quality: Source document reviews, query resolution, and ensuring accuracy and completeness of case report forms (CRFs).
  • Investigational Product Oversight: Managing inventory, reconciliation, and compliance with protocol and GCP regulations.
  • Documentation: Preparing confirmation letters, trip reports, and tracking observations to ensure timely resolution of issues.
  • Training & Communication: Acting as a liaison between study site personnel and project teams, facilitating training, and participating in investigator meetings.
  • Audit Readiness: Supporting preparation for audits and compliance with organizational and regulatory requirements.
  • Real-World Late Phase Studies: Additional tasks like chart abstraction and collaborating with local stakeholders for late-phase study designs.

Key Differences

CRA II

  • Experience: Minimum of 3 years in onsite and remote monitoring.
  • Therapeutic Expertise: Neurology, immunology, rare diseases, CVD, and oncology are preferred.
  • Role Scope: May require closer guidance and oversight compared to senior roles.
  • Locations: Candidates from Mumbai, Delhi, Bengaluru, Hyderabad, Ahmedabad preferred.

Sr CRA

  • Experience: Minimum of 4 years in a relevant field, emphasizing oncology and cardiovascular disease (CVD) therapeutic areas.
  • Leadership: Expected to work with greater independence and provide guidance to junior staff or peers.
  • Complex Study Management: Greater involvement in managing advanced therapeutic area studies and adapting to higher-level challenges.
  • Locations: Specifically prefers candidates from Mumbai, Delhi, Bengaluru, Hyderabad, indicating high-priority project locations.

Shared Qualifications

  • Bachelor's degree or RN in a related field.
  • Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
  • Strong computer skills with the ability to adopt new technologies.
  • Excellent communication and interpersonal skills.
  • Ability to travel up to 75% of the time.

Overall, both roles are integral to ensuring the quality and compliance of clinical trials, with the Sr CRA role offering greater responsibilities and autonomy aligned with a higher level of experience.